Blood health monitoring method and device

ABSTRACT

A wearable analyte breath alert device and method for non-invasive monitoring of an analyte in a sample from a user. The device comprises an outer casing, a forward face having an in-line insignia, a front port and an activation button, a rear face having a detector threshold region, a side port and a LED indicator, a reversible core having a main processor module and a volatile organic compound (VOC) sensor adaptable to detect at least one volatile organic compound of the user. The VOC sensor further comprises a central sensor circuit having at least one nano gas sensor, a sensor signal conditioning unit and an A/D interface. The central sensor circuit is operably connected to a Bluetooth Low Energy (BLE) element having a microcontroller. An alarm component is coupled with the BLE element that alerts the user based on the analyte detected by the nano gas sensor.

RELATED APPLICATIONS AND PRIORITY

This application claims priority from U.S. nonprovisional patentapplication Ser. No. 17/891,024 filed Aug. 18, 2022 and granted Jan. 3,2023 as U.S. patent Ser. No. 11/540,753, and which claims priority toprovisional patent application 63/235,642, filed Aug. 20, 2021, which isincorporated by reference herein as if set out in full.

BACKGROUND OF THE DISCLOSURE Technical Field of the Disclosure

The present invention relates generally to a device and methods forblood aerosolized analyte measurement, and more particularly to a deviceand a method for monitoring the presence, amount, and/or concentrationof a chemical species in a gaseous sample wherein the chemical speciesis selected to be indicative of/or related to a physiological status ofa user, for example the blood glucose level or volatile organic compoundlevel in a user's breath.

Description of the Related Art

Traditional personal health monitors may be bulky, rigid, anduncomfortable—generally not suitable for use during daily physicalactivity or continuous use throughout the working day. As such, improvedmeans for collecting, storing and analyzing personal health andenvironmental information are needed. In addition, improved ways ofdistributing raw and analyzed personal health information are desirableto support efforts to enhance healthcare quality and reduce costs.Traditional personal health monitors are adapted to facilitatemeasurement and management of a variety of conditions, includingdiabetes.

Diabetes is a disease in which an amount of glucose in the blood of apatient is excessively small or excessively large. Diabetes may developwhen insulin production is dysregulated in the bloodstream, pancreas andrelated organs. In addition, diabetes may develop when secreted insulinaction is dysregulated often due to dietary and/or genetic factors. Forexample, consider a subject with type 1 diabetes.

In order to adequately manage type 1 diabetes, the subject is requiredto monitor blood glucose concentrations accurately and at regularintervals through the day. If blood glucose concentrations are too high(hyperglycemia) or too low (hypoglycemia), corrective action on the partof the subject must be taken to avoid serious consequences. As is wellknown in the art, hypoglycemia can result in seizures, coma, and evendeath.

Traditionally, blood glucose levels are measured by collecting a bloodsample and subsequently directly measuring a concentration of glucose inthe collected blood sample. However, a user often feels pain when his orher skin is stuck by a needle, for example, during the collection of ablood sample.

Further to the above, many individuals suffer from non-diabeticconditions that require routine monitoring of an aerosolized analyte(i.e., determining the concentration of the gas phase analyte). Forexample, continuous measurement of volatile organic compounds (“VOCs”)can indicate that a subject is suffering from or likely to suffer from agiven disease or condition such as impending heart attack.

In addition, various studies report a correlation between one or moreanalytes and a given disease or condition rather than a causative linkbetween an analyte and a condition. This fact suggests that continuousmeasurement of aerosolized compounds has a wide array of applications.By monitoring one or more analytes related to, for example, VOCsassociated with hypothyroidism, a subject may be alerted that he/she isin danger of hypothyroid related arrhythmias, weight gain, or decreasesin blood pressure.

Furthermore, an increasingly large percentage of total healthcarespending is allocated to the care and treatment of subjects withconditions that may be ameliorated by continuous monitoring. Inparticular, healthcare costs are rising for those individuals that donot adequately monitor their atherosclerosis-related conditions (i.e.,an angina patient who fails to adequately monitor C-Reactive Protein).

One reason patients fail to monitor such conditions is that monitoringcan be painful (i.e., a finger stick), physically cumbersome, expensive,and requires the user to seek out poorly marketed special equipment thatoften must be transported to the user. In addition, in many casesrequiring monitoring, the prescribed frequency of monitoring intervalsis so high that patients choose to forgo monitoring entirely.

Thus, the devices and methods of the prior art suffer from drawbacks andshortcomings that result in decreased monitoring in patient populationsthat benefit significantly from continuous monitoring.

Therefore, there is a need for a device and a method for measuring bloodglucose continuously and without the need to collect a liquid bloodsample. Such a needed device and method would non-invasively monitor auser's blood glucose level by measuring aerosolized acetone and similarvolatile organic compounds indicative of glucose levels from the breathof the user. Further, such a device and method would alert the userbased on set high and low glucose levels. Moreover, such a device andmethod would provide a variety of means to alert the user includinghaptic, LED light array, programmable voice alert, and alert to a smartdevice. Such a device and method would have an automated means ofcommunicating dangerous glucose levels to third parties through.Moreover, such a device and method would monitor blood glucoseconcentrations accurately and at regular intervals through the day toavoid serious health consequences. Further, such a device and methodwould provide a painless, small, cost effective, stylish and highlyfunctional device that can be worn by the user. The present embodimentovercomes shortcomings in the field by accomplishing these criticalobjectives.

SUMMARY OF THE DISCLOSURE

To minimize the limitations found in the prior art, and to minimizeother limitations that will be apparent upon the reading of thespecification, the present application provides a method and a device toalert a user based on the concentration of an analyte in a sample fromthe breath of the user. The present application provides a wearableanalyte breath alert device for non-invasive monitoring of theconcentration of glucose in an aerosolized volatile organic compoundfrom the breath of the user. The sample can be any aerosolized gas orfluid that emanates from the user and contains the analyte. The analytecan be selected from a group consisting of: glucose, acetone, ketone orany volatile organic compound.

The device comprises an outer casing, a forward face, a rear faceopposite thereto, a reversible core, a volatile organic compound (VOC)sensor and a securement means. The outer casing is made of materialsselected from a group consisting of: Polycarbonate/acrylonitrilebutadiene styrene (PC/ABS) plastics, silicone rubber, and nylon. Theforward face is secured to the outer casing and includes an in-lineinsignia, a front port and an activation button. The rear face isopposite the forward face and is secured to the outer casing. The rearface includes a detector threshold region, a side port and a LEDindicator. The front port and the detector threshold region isconfigured to function as gas sensor intake ports, speaker ports,Bluetooth sensors and/or cooling ports or evacuation/purge ports forpurging or evacuating a previous breath sample from the device. Thereversible core includes a main processor and is positioned in betweenthe outer casing, the forward face and the rear face. The volatileorganic compound (VOC) sensor is adaptable to detect at least onevolatile organic compound of the user. The VOC sensor is positioned onthe main processor module. The VOC sensor includes a central sensorcircuit operably connected to a Bluetooth Low Energy (BLE) elementhaving a microcontroller, an alarm component and a DC to DC elementhaving a battery charger and a battery. The central sensor circuitfurther comprises a gas sensor unit having at least one nano gas sensorand at least one heater, a sensor signal conditioning unit having a gainelement and a conversion element, and an A/D interface having an analogto digital converter and a digital to analog converter. The at least onenano gas sensor is extremely sensitive and detects the analyte presentin the sample. The alarm component includes an audio piezo actuator, avibration element, and a tri-color light emitting diode (LED). The alarmcomponent further includes an alarm timing means that allows the user toprogram alerts and record glucose levels at regular intervals. The alarmcomponent alerts the user based on the detected analyte at intervalscontrolled by the user or on demand. The outer casing is adaptable toattach with the securement means and the securement means is configuredto attach the device with the user. In the preferred embodiment, thesecurement means is a neck securement means and the preferred device isa necklace. The securement means includes a fitting means including asnap fitting and/or magnetic engagement fitting means. Notably, thefitting means may further include a screw fit and/or adhesive engagementmeans. In an alternate embodiment, the securement means can be a wristsecurement, and/or a clothing clipping securement. In an alternateembodiment, the device can be a wristwatch and/or a device adaptable toattach to a clothing. In the alternate embodiment, the wristwatch,includes a wrist securement, a watch casing and a plurality of claspingholes, and neck securement.

The present application provides a method for detecting acetone, ketonesand other volatile organic compounds present in the breath of the userand alerts the user based on the concentration of acetone, ketones andother volatile organic compounds. The method comprises the steps of:providing a wearable analyte breath alert device having a front port, adetector threshold region, a volatile organic compound (VOC) sensoroperably coupled to a Bluetooth Low Energy (BLE) element having amicrocontroller and an alarm component for non-invasive monitoring of ananalyte in a sample from a user. Then, introducing the sample to the VOCsensor through the front port and the detector threshold region of thewearable analyte breath alert device. Introducing the sample to the VOCsensor includes introducing the user's breath onto the front port andthe detector threshold region of the wearable analyte breath alertdevice. The method detects the presence of the analyte in the sample byan at least one nano gas sensor in the VOC sensor and generates a signalby the at least one nano gas sensor based on the presence, amount andconcentration of the analyte in the sample. Then transmitting the signalto the microcontroller of the BLE element and the microcontrolleranalyze the signal to produce a result. Finally, the alarm componentalerts the user based on the result from the microcontroller.

A first objective of the present embodiment is to provide a device and amethod for measuring blood glucose continuously and without the need tocollect a liquid blood sample.

A second objective of the present embodiment is to provide a device anda method that non-invasively monitors a user's blood glucose level bymeasuring aerosolized acetone and similar volatile organic compoundsindicative of glucose levels from the breath of the user.

A third objective of the present embodiment is to provide a device andmethod that alerts the user based on set high and low glucose levels.

Yet another objective of the present embodiment is to provide a deviceand method that provides a variety of means to alert the user includinghaptic, LED light array, programmable voice alert, and alert to a smartdevice.

Yet another object of the present embodiment is to provide a device andmethod that provides an automated means for communicating dangerousglucose levels to third parties through the smart device.

Yet another object of the present embodiment is to provide a device andmethod that monitors blood glucose concentrations accurately and atregular intervals through the day to avoid serious health consequences.

Yet another object of the present embodiment is to provide a device andmethod that provides a painless, small, cost effective, stylish andhighly functional device that can be worn by the user.

These and other advantages and features of the present invention aredescribed with specificity so as to make the present inventionunderstandable to one of ordinary skill in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to enhance their clarity and improve the understanding of thevarious elements and embodiment shown herein, the figures have notnecessarily been drawn to scale. Furthermore, elements that are known tobe common and well understood to those in the industry are not depictedin order to provide a clear view of the various embodiments of theinvention, thus the drawings are generalized in form in the interest ofclarity and conciseness.

FIG. 1A illustrates a front view of a wearable analyte breath alertdevice for non-invasive monitoring of an analyte in a sample from a userin accordance with the preferred embodiment of the present invention;

FIG. 1B illustrates a front perspective view of the wearable analytebreath alert device in accordance with the preferred embodiment of thepresent invention;

FIG. 1C illustrates a rear perspective view of the wearable analytebreath alert device in accordance with the preferred embodiment of thepresent invention;

FIG. 1D illustrates a rear perspective view of the wearable analytebreath alert device with a higher intensity LED indicator in accordancewith the preferred embodiment of the present invention;

FIG. 1E illustrates a rear perspective view of the wearable analytebreath alert device with one embodiment of a detector threshold regionin accordance with the preferred embodiment of the present invention;

FIG. 2A illustrates a front perspective view a reversible core detachedfrom an outer casing of the wearable analyte breath alert device inaccordance with the preferred embodiment of the present invention;

FIG. 2B illustrates a front perspective view the reversible core securedto the outer casing of the wearable analyte breath alert device inaccordance with the preferred embodiment of the present invention;

FIG. 3 illustrates a block diagram of a volatile organic compound (VOC)sensor of the wearable analyte breath alert device in accordance withthe preferred embodiment of the present invention;

FIG. 4 illustrates a block diagram of a main processor module of thewearable analyte breath alert device in accordance with the preferredembodiment of the present invention;

FIG. 5 illustrates a circuit diagram of a central sensor circuit of thewearable analyte breath alert device in accordance with the preferredembodiment of the present invention;

FIG. 6 illustrates a circuit diagram of an alarm component of thewearable analyte breath alert device in accordance with the preferredembodiment of the present invention;

FIGS. 7A-7C illustrate a circuit diagram of a Bluetooth Low Energy (BLE)element having a microcontroller of the wearable analyte breath alertdevice in accordance with the preferred embodiment of the presentinvention;

FIGS. 8A-8B illustrate a circuit diagram of a charger and power circuitof the wearable analyte breath alert device in accordance with thepreferred embodiment of the present invention;

FIG. 9 illustrates a circuit diagram of a volatile organic compound(VOC) sensor of the wearable analyte breath alert device in accordancewith the preferred embodiment of the present invention;

FIG. 10 illustrates a circuit diagram of a humidity and temperaturesensor of the wearable analyte breath alert device in accordance withthe preferred embodiment of the present invention;

FIG. 11 illustrates a front view of a wearable analyte breath alertdevice in accordance with an alternate embodiment of the presentinvention;

FIG. 12A illustrates a perspective view of the reversible core detachedfrom a watch casing of the wearable analyte breath alert device inaccordance with an alternate embodiment of the present invention;

FIG. 12B illustrates a perspective view of the reversible core securedto the watch casing of the wearable analyte breath alert device inaccordance with an alternate embodiment of the present invention;

FIG. 13A illustrates a front view of the wearable analyte breath alertdevice in accordance with another embodiment of the present invention;

FIG. 13B illustrates a side view of the wearable analyte breath alertdevice in accordance with another embodiment of the present invention;

FIG. 13C illustrates a front perspective view of the wearable analytebreath alert device in accordance with another embodiment of the presentinvention; and

FIG. 14 illustrates a flowchart of a method for detecting acetone,ketones and other volatile organic compounds in the breath of a userutilizing the wearable analyte breath alert device in accordance withthe preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

In the following discussion that addresses a number of embodiments andapplications of the present invention, reference is made to theaccompanying drawings that form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. It is to be understood that other embodiments may beutilized, and changes may be made without departing from the scope ofthe present invention.

Various inventive features are described below that can each be usedindependently of one another or in combination with other features.However, any single inventive feature may not address any of theproblems discussed above or only address one of the problems discussedabove. Further, one or more of the problems discussed above may not befully addressed by any of the features described below.

As used herein, the singular forms “a”, “an” and “the” include pluralreferents unless the context clearly dictates otherwise. “And” as usedherein is interchangeably used with “or” unless expressly statedotherwise. As used herein, the term ‘about” means+/−10% of the recitedparameter. All embodiments of any aspect of the invention can be used incombination, unless the context clearly dictates otherwise.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words ‘comprise’, ‘comprising’, and thelike are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to”. Words using the singular or pluralnumber also include the plural and singular number, respectively.Additionally, the words “herein,” “wherein”, “whereas”, “above,” and“below” and words of similar import, when used in this application,shall refer to this application as a whole and not to any particularportions of the application.

The description of embodiments of the disclosure is not intended to beexhaustive or to limit the disclosure to the precise form disclosed.While the specific embodiments of, and examples for, the disclosure aredescribed herein for illustrative purposes, various equivalentmodifications are possible within the scope of the disclosure, as thoseskilled in the relevant art will recognize.

Referring to FIGS. 1A-10 , a wearable analyte breath alert device 10 fornon-invasive monitoring of an analyte in a sample from a user isillustrated. The preferred embodiment provides a breath alert device 10which is more specifically a wearable non-invasive glucose breath alertdevice 10 used to alert the user of high or low blood sugar. Thewearable analyte breath alert device 10 is configured to measureaerosolized volatile organic compounds or similar compounds.

The sample can be any aerosolized gas or fluid that emanates from theuser and contains the analyte (i.e., gaseous or fluid aerosolizedblood). In one embodiment, the sample is an indirect sample. An indirectsample is a sample that is not introduced directly into the inlet portsof the breath alert device 10 by the user (for example, the userbreathing through a tube into the inlet ports of the breath alert device10). In one embodiment, the sample is co-mingled with the ambientenvironment of the user (for example, ambient air) before beingintroduced into the breath alert device 10. In a particular embodiment,the sample is ambient air that surrounds the breath alert device 10 andthe user. When the sample is ambient air, the analyte originates from oris derived from the user of the breath alert device 10 and becomes mixedwith ambient air such that the target analyte is contained in theambient air surrounding the user. For example, the user of the breathalert device 10 may exhale the analyte in breath, excrete the analytethrough skin (VOCs are volatile at body temperature), excrete theanalyte through perspiration, excrete the analyte through eccrineglands, apocrine glands, and/or sebaceous glands, or any combination ofthe foregoing, such that the analyte is mixed with the ambient air.

As described above, the sample may also be a direct sample meaning thatthe user directly introduces the sample into the breath alert device 10(i.e., breathes into the inlets ports). A direct sample may be usefulfor calibrating the breath alert device 10 or may be required when theuser is in an environment where an indirect sample is not feasible (forexample, when the user is in a high wind environment or a closedenvironment with a high concentration of VOCs or other compounds thatinterfere with the detection of the analyte). In certain embodiments,the sample is ambient air containing an analyte emanating from the user(for example, an analyte contained in an exhaled breath or excreted fromthe user). In certain embodiments, the sample is exhaled breath. Incertain embodiments the sample is exhaled breath and the sample isdirectly introduced into the breath alert device 10 by the user (forexample, the user exhales a breath directly into the inlet ports of thedevice 10).

The analyte can be selected from a group consisting of: glucose,acetone, ketone or any volatile organic compound. In a preferredembodiment, the analyte detected by the breath alert device 10 isglucose, acetone, a VOC, or the like. Notably, the composition ofemitted compounds, particularly VOCs, can differ between healthyindividuals and individuals with a specific disease or condition and canbe indicative or related to a given physiological status of the user.

In one embodiment, the analyte is present in the sample at aconcentration greater than or equal to 1 part per billion (ppb) and lessthan or equal to 1000 parts per million (ppm). In another embodiment,the analyte is present in the sample at a concentration greater than orequal to 1 part per ppb and less than or equal to 100 ppm. In anotherembodiment, the analyte is present in the sample at a concentrationgreater than or equal to 1 part per ppb and less than or equal to 10ppm. In another embodiment, the analyte is present in the sample at aconcentration greater than or equal to 10 parts per ppb and less than orequal to 1000 ppm. In another embodiment, the analyte is present in thesample at a concentration greater than or equal to 100 parts per ppb andless than or equal to 1000 ppm. In another embodiment, the analyte ispresent in the sample at a concentration greater than or equal to 1 partper ppm and less than or equal to 1000 ppm. In another embodiment, theanalyte is present in the sample and detected by the breath alert device10 at a concentration between 1 part per ppb and 10 ppm. In anotherembodiment, the analyte is present in the sample at a concentrationbetween 1 part per ppb and 750 ppb.

Many VOCs emitted by humans have been correlated with certain diseases.Therefore, in certain embodiments, the analyte is a VOC. A variety ofVOCs may be detected by the breath alert device 10 of the presentapplication. In one embodiment, any VOC known in the art to beassociated with a physiological status, a predisposition of aphysiological status, a disease or condition, or a predisposition to adisease or condition may be detected. In one embodiment, a VOC is anycarbon based compound with a vapor pressure greater than 0.01 kPa at293.15 K (20° C.).

In one embodiment, the analyte is a VOC and the VOC is present in thesample and detected by the breath alert device 10 at a concentrationgreater than or equal to 1 part per billion (ppb) and less than or equalto 1000 parts per million (ppm). In another embodiment, the analyte is aVOC and the VOC is present in the sample at a concentration greater thanor equal to 1 part per ppb and less than or equal to 100 ppm. In anotherembodiment, the analyte is a VOC and the VOC is present in the sample ata concentration greater than or equal to 1 part per ppb and less than orequal to 10 ppm. In another embodiment, the analyte is a VOC and the VOCis present in the sample at a concentration greater than or equal to 10parts per ppb and less than or equal to 1000 ppm. In another embodiment,the analyte is a VOC and the VOC is present in the sample at aconcentration greater than or equal to 100 parts per ppb and less thanor equal to 1000 ppm. In another embodiment, the analyte is a VOC andthe VOC is present in the sample at a concentration greater than orequal to 1 part per ppm and less than or equal to 1000 ppm. In anotherembodiment, the analyte is a VOC and the VOC is present in the sample ata concentration between 1 part per ppb and 10 ppm. In anotherembodiment, the analyte is a VOC and the VOC is present in the sample ata concentration between 1 part per ppb and 750 ppb.

In certain embodiments, a single VOC is detected by the breath alertdevice 10. In other embodiments, more than a single VOC is detected bybreath alert device 10 of the present application. In one embodiment,the VOC detected is acetone, methyl nitrate, pentyl nitrate (forexample, 2-pentyl nitrate), ethanol, methanol, propanol, methane,propane, ethyl benzene, isoprene, O-xylene (ortho-xylene), formaldehyde,acetaldehyde, or any combination of the foregoing. In anotherembodiment, the VOC detected is acetone, methyl nitrate, pentyl nitrate(for example, 2-pentyl nitrate), ethanol, methanol, propanol, methane,propane, ethyl benzene, isoprene or any combination of the foregoing.

In another embodiment, the detected VOC is acetone and methyl nitrate,pentyl nitrate (for example, 2-pentyl nitrate), ethanol, methanol,propanol, methane, propane, ethyl benzene, isoprene, O-xylene,MIP-xylene, formaldehyde, acetaldehyde, or any combination of theforegoing. In another embodiment, the detected VOC is acetone and methylnitrate, pentyl nitrate (for example, 2-pentyl nitrate), ethanol,methanol, propanol, methane, propane, ethyl benzene, isoprene, or anycombination of the foregoing. In another embodiment, the detected VOC isacetone and pentyl nitrate (for example, 2-pentyl nitrate), methanol,propane, isoprene, or any combination of the foregoing. In anotherembodiment, the detected VOC is one or more of acetone, pentyl nitrate(for example, 2-pentyl nitrate), methanol, propane, or isoprene. Inanother embodiment, the detected VOC is each acetone, pentyl nitrate(for example, 2-pentyl nitrate), methanol, propane, or isoprene. Inanother embodiment, the detected VOC is ethanol and methyl nitrate,pentyl nitrate (for example, 2-pentyl nitrate), acetone, methanol,propanol, methane, propane, ethyl benzene, isoprene, O-xylene,MIP-xylene, formaldehyde, acetaldehyde, or any combination of theforegoing. In another embodiment, the detected VOC is ethanol and methylnitrate, pentyl nitrate (for example, 2-pentyl nitrate), ethanol,acetone, propanol, methane, propane, ethyl benzene, isoprene, or anycombination of the foregoing. In another embodiment, the detected VOC isethanol and one or more of methyl nitrate or ethyl benzene. In anotherembodiment, the detected VOC is each of ethanol, methyl nitrate andethyl benzene.

In another embodiment, the detected VOC by the breath alert device 10 isisoprene and acetone, methyl nitrate, pentyl nitrate (for example,2-pentyl nitrate), ethanol, methanol, propanol, methane, propane, ethylbenzene, formaldehyde, acetaldehyde, or any combination of theforegoing. In certain embodiments, the VOC detected is acetone andoptionally 1 or more additional VOCs. In certain embodiments, the VOCdetected is isoprene and optionally or more additional VOCs. In certainembodiments, the VOC detected is methyl nitrate and optionally 1 or moreadditional VOCs. In certain embodiments, the VOC detected is pentylnitrate (for example, 2-pentyl nitrate) and optionally 1 or moreadditional VOCs. In certain embodiments, the VOC detected is ethanol andoptionally 1 or more additional VOCs. In certain embodiments, the VOCdetected is methanol and optionally 1 or more additional VOCs. Incertain embodiments, the VOC detected is propanol and optionally 1 ormore additional VOCs. In certain embodiments, the VOC detected ismethane and optionally 1 or more additional VOCs. In certainembodiments, the VOC detected is propane and optionally 1 or moreadditional VOCs. In certain embodiments, the VOC detected is ethylbenzene and optionally 1 or more additional VOCs. In certainembodiments, the VOC detected is O-xylene and optionally 1 or moreadditional VOCs. In certain embodiments, the VOC detected is M/P-xyleneand optionally 1 or more additional VOCs. In certain embodiments, theVOC detected is formaldehyde and optionally 1 or more additional VOCs.In certain embodiments, the VOC detected is acetaldehyde and optionally1 or more additional VOCs.

When more than one VOC is detected by the breath alert device 10 atleast 2 VOCs may be detected, at least 3 VOCs may be detected, at least4 VOC may be detected, at least 5 VOCs may be detected, at least 6 VOCsmay be detected, at least 7 VOCs may be detected, at least 8 VOCs may bedetected, at least 9 VOCs may be detected, or more than 9 VOCs may bedetected. In the foregoing, the upper range for the number of VOCsdetected may be 15, 20, 25 or 50 VOCs. Therefore, as one example, whenat least 2 VOCs are detected, from 2 to 15 VOCs, from 2 to 10 VOCs, from2 to 5 VOCs, from 2 to 4 VOCs, or from 2 to 3 VOCs may be detected bythe sensor system.

While the present disclosure provides for the detection of VOCsregardless of the reason why such VOC is associated with a particularphysiological status, scientific principles may inform what VOCs may beassociated with a particular physiological status. Human breath iscomposed of inhaled air, CO₂, water vapor, small amounts of proteins,and VOCs. The VOCs are created through a variety of physiologicalprocess and non-physiological processes, including, but not limited to,internal metabolic reactions, metabolic reactions from bacteria or otherorganisms present in the body, as gases produced for physiologicalsignaling roles, or as metabolites from inhaled atmospheric components.By way of example only, the following provides a scientific basis forthe utility of selected VOCs in the determination of a hypoglycemia.Pentyl nitrate (for example, 2-pentyl nitrate) and methyl nitrate may begenerated through pathways involving organic peroxy radical, superoxideion, or other byproducts of oxidative reactions. As oxidative stress isassociated with hypoglycemia, levels of these compounds may reflectchanges in oxidative status indicative of hypoglycemia.

Ethanol methanol, propanol, and propane production may be due activityof gut flora bacteria (for example, alcoholic fermentation of glucose bygut bacteria and yeast). As such, the levels of ethanol raid methanolare responsive to fluctuations in glucose concentration. Ethyl benzene,O-xylene, and M/P-xylene are generally inhaled, partly metabolized byliver, and then exhaled at lower concentration. Rapid-onsethyperglycemia may suppress hepatic metabolism causing increasedconcentration of these compounds in exhaled air. In one embodiment, thephysiological status detected by the breath alert device 10 ishypoglycemia and the VOC is acetone, methyl nitrate, pentyl nitrate (forexample, 2-pentyl nitrate), ethanol, methanol, propanol, methane,propane, ethyl benzene, isoprene, O-xylene, M/P-xylene, formaldehyde,acetaldehyde or combinations of the foregoing.

In certain embodiments, the physiological status is hypoglycemia and theVOC detected is: (1) acetone, methyl nitrate, pentyl nitrate (forexample, 2-pentyl nitrate), ethanol, methanol, propanol, methane,propane, ethyl benzene, isoprene, O-xylene, M/P-xylene formaldehyde,acetaldehyde, or any combination of the foregoing; (2) acetone, methylnitrate, pentyl nitrate (for example, 2-pentyl nitrate), ethanol,methanol, propanol, methane, propane, ethyl benzene, isoprene or anycombination of the foregoing; (3) acetone and methyl nitrate, pentylnitrate (for example, 2-pentyl nitrate), ethanol, methanol, propanol,methane, propane, ethyl benzene, isoprene, O-xylene, M/P-xylene,formaldehyde, acetaldehyde, or any combination of the foregoing; (4)acetone and methyl nitrate, pentyl nitrate (for example, 2-pentylnitrate), ethanol, methanol, propanol, methane, propane, ethyl benzene,isoprene, or any combination of the foregoing; (5) acetone and pentylnitrate (for example, 2-pentyl nitrate), methanol, propane, isoprene, orany combination of the foregoing; (6) ethanol and methyl nitrate, pentylnitrate (for example, 2-pentyl nitrate), acetone, methanol, propanol,methane, propane, ethyl benzene, isoprene, O-xylene, M/P-xylene,formaldehyde, acetaldehyde, or any combination of the foregoing; (7)ethanol and methyl nitrate, pentyl nitrate (for example, 2-pentylnitrate), ethanol, acetone, propanol, methane, propane, ethyl benzene,isoprene, or any combination of the foregoing; (8) ethanol and methylnitrate, ethyl benzene, or any combination of the foregoing; (9)isoprene and acetone, methyl nitrate, pentyl nitrate (for example,2-pentyl nitrate), ethanol, methanol, propanol, methane, propane, ethylbenzene, O-xylene, M/P-xylene, formaldehyde, acetaldehyde, or anycombination of the foregoing; 10) ethanol, methyl nitrate, and ethylbenzene; or 11) acetone, pentyl nitrate (for example, 2-pentyl nitrate),methanol, propane, and isoprene.

In certain embodiments, the physiological status is hypoglycemia and theVOC detected is acetone and optionally 1 or more additional VOCs. Incertain embodiments, the physiological status is hypoglycemia and theVOC detected is isoprene and optionally 1 or more additional VOCs. Incertain embodiments, the physiological status is hypoglycemia and theVOC detected is methyl nitrate and optionally 1 or more additional VOCs.In certain embodiments, the physiological status is hypoglycemia and theVOC detected is pentyl nitrate (for example, 2-pentyl nitrate) andoptionally 1 or more additional VOCs. In certain embodiments, thephysiological status is hypoglycemia and the VOC detected is ethanol andoptionally 1 or more additional VOCs. In certain embodiments, thephysiological status is hypoglycemia and the VOC detected is methanoland optionally 1 or more additional VOCs. In certain embodiments, thephysiological status is hypoglycemia and the VOC detected is propanoland optionally 1 or more additional VOCs. In certain embodiments, thephysiological status is hypoglycemia and the VOC detected is methane andoptionally 1 or more additional VOCs.

In certain embodiments, the physiological status is hypoglycemia and theVOC detected is propane and optionally 1 or more additional VOCs. Incertain embodiments, the physiological status is hypoglycemia and theVOC detected is ethyl benzene and optionally 1 or more additional VOCs.In certain embodiments, the physiological status is hypoglycemia and theVOC detected is O-xylene and optionally 1 or more additional VOCs. Incertain embodiments, the physiological status is hypoglycemia and theVOC detected is M/P-xylene and optionally 1 or more additional VOCs. Incertain embodiments, the physiological status is hypoglycemia and theVOC detected is formaldehyde and optionally 1 or more additional VOCs.In certain embodiments, the physiological status is hypoglycemia and theVOC detected is acetaldehyde and optionally 1 or more additional VOCs.

Although many volatile organic compounds (VOCs) can be detected by thebreath alert device 10, other respiratory aerosols can be detected aswell. For instance, in addition to endogenous metabolites and exogenouscompounds, droplet and aerosols including proteins, viral DNA/RNA, viralparticles, non-volatile metabolites and even drugs or alcohol can bedetectable. For example, C₁₅H₃₀ 1-pentadecene, 3-methyl-1-butanal,octane, acetic acid, alpha-pinene, and m-cymene are elevated in activeulcerative colitis. In another example, VOCs such as pentanoic acid,hexanoic acid, phenol, methyl phenol, ethyl phenol, butanal, pentanal,hexanal, heptanal, octanal, nonanal, and decanal—may be present atsignificantly higher concentrations in cancer groups than in thenoncancer controls. Others may include VOCs such as acetaldehyde,styrene, decane, isoprene, benzene, 2,3,3-trimethylpentane,2,3,5-trimethylhexane, 2,4-dimethylheptane, 4-methyloctane,acetaldehyde, 3-methylbutanal, n-butyl acetate, acetonitrile, acrolein,methacrolein, 2-methylpropanal, 2-butanone, 2-methoxy-2-methylpropane,2-ethoxy-2-methylpropane, hexanal, 2-ethyl-1-hexanol, 2-methylpenthane,acetaldehyde, 2-methylpropanal, 3-methylbutanal, 2-methylbutanal,hexanal, n-butyl acetate, 2-pentanone, 2-methyl-1-pentene,2,4-dimethyl-1-heptene, acetone, ethanol, isobutene, n-octane,tert-butyl methyl ether, tert-butyl ethyl ether, n-butyl acetate,3-methylbutanal, 2-methylpropanal, methacrolein, 2-methyl-2-butenal,2-ethylacrolein, pyrrole, dimethyl succinate, 2-pentanone, phenol,2-methylpyrazine, 2-hexanone, acetophenone, benzophenone, maltol,dimethyl disulfide, methanethiol, 1-butanol, acetonitrile,cyclohexanone, tributyl phosphate, 2-methyl-1-propanal, benzyl alcohol,styrene, decanal 2-pentadecanone, nonadecane, eicosane, benzaldehyde,2-ehtyl-1-hexanol, 2,4-decadien-1-ol n-propyl benzene,1-ethyl-2-methylbenzene, styrene, dodecane, cyclohexanol, decanal,nonanal, 1,3-Di-tert-butylbenzene, tetradecane, 2-ethyl-1-dodecanol,2-ethylhexanol, benzaldehyde, acetophenone, 2-Ethyl-m-xylene,1-methyl-2-pyrrolidinone, and heneicosane.

The wearable analyte breath alert device 10 comprises an outer casing16, a forward face 12, a rear face 24, a reversible core 11, a volatileorganic compound (VOC) sensor 38 and a securement means 14 adaptable toattach with the outer casing 16. The forward face 12 and the rear face24 are secured to the outer casing 16. The forward face 12 includes anin-line insignia 13, a front port 18 and an activation button 20. Thefront port 18 is configured to function as gas sensing port, speakerport and lidar sensor port. The activation button 20 is configured toactivate a device function. The device function includes indication ofthe device battery level, setting the alert levels etc. The rear face 24is opposite to the forward face 12 and includes a detector thresholdregion 22, a side port 34 and an LED indicator 54. The detectorthreshold region 22 includes a plurality of circular holes 94 which isconfigured to function as gas sensor intake ports, speaker ports,Bluetooth sensors and/or cooling ports or ports for purging a previoussample. The ports may also include a means for evacuating a previoussample and for the user's breath to exit the device. The reversible core11 includes a main processor module 72 and the reversible core 11 ispositioned in between the outer casing 16, the forward face 12 and therear face 24. The volatile organic compound (VOC) sensor 38 is adaptableto detect at least one volatile organic compound of the user. The VOCsensor 38 is positioned on the main processor module 72. The VOC sensor38 further comprises a central sensor circuit 70 operably connected to aBluetooth Low Energy (BLE) element 56 having a microcontroller (MCU), analarm component 50 and a DC to DC element 42. The central sensor circuit70 includes a gas sensor unit 86 having at least one nano gas sensor 64and at least one heater 66, a sensor signal conditioning unit 88 havinga gain element 60 and a conversion element 62, and an A/D interface 90having an analog to digital converter (ADC) 58 and a digital to analogconverter (DAC) 68. The alarm component 50 includes an audio piezoactuator 52, a vibration element 48, and a tri-color light emittingdiode (LED) 54. The DC to DC element 42 includes a battery charger 40and a battery 46. The securement means 14 is a neck securement means.The breath alert device 10 of the preferred embodiment is a necklace.

FIGS. 1A and 1B illustrate the forward face 12 of the wearable analytebreath alert device 10 which includes the in-line insignia 13, the frontport 18 and the activation button 20. The front port 18 is configured tofunction as gas sensing port, speaker port and lidar sensor port. Theouter casing 16 of the breath alert device 10 is made of materialsselected from a group consisting of: plastic, neoprene, leathercomplexed with plastics, waterproof materials, polyvinyls, and the like.In some embodiments, the in-line insignia 13 and the circular portionaround the in-line insignia 13 can take on a variety of mechanicalsensations, colors, and designs. In one embodiment, the front port 18 isutilized as an intake leading to the at least one nano gas sensor 64 andthe central sensor circuit 70. In other embodiments, the front port 18is utilized as a speaker port or a means to communicate with the user'sphone 44 or an alternate device. In some embodiments, the front port 18is utilized for many functions including but not limited to speakerport, gas sensing port, BLE transmitter, lidar sensor port, and/othersensors and ports known in the art. In some embodiments, the activationbutton 20 provides a means of user interface with the VOC sensor circuit70, permitting the user to set high glucose and low glucose alertlevels, set alert types, control the units of display, and the like.

As shown in FIG. 1B, the front perspective view of the wearable analytebreath alert device 10 shows the relatively thin mechanical design ofthe wearable analyte breath alert device 10. This design, of the presentapplication, ensures that the user is not encumbered by a bulky, heavygas sensing device; a problem faced by other glucose sensing devicesknown in the art.

As illustrated in FIG. 1A, the forward face 12 of the breath alertdevice 10 may include the LED indicator 54. The LED indicator 54comprises colored lights shown as a means of electronic communication atdifferent intensities, flashing frequencies, and colors (i.e., bluecoloration, red coloration, green coloration, and the like). Theelectronic communication may indicate low battery, high glucose levelalert, low glucose level art, battery charging indicator, pairingindicator, and the like.

FIG. 1C illustrates a rear perspective view of the wearable analytebreath alert device 10 in accordance with the preferred embodiment ofthe present invention. The rear face 24 includes the detector thresholdregion 22, the side port 34 and the LED indicator 54. The detectorthreshold region 22 functions as intake ports, speaker ports, Bluetoothsensors, cooling ports, and/other sensors and ports known in the art.Further, in some embodiments the side port 34 serve as speaker ports,Bluetooth sensors, cooling ports, sample or breath purging ports,temperature sensors, and/or other similar elements known in the art.

In FIG. 1D, the rear face 24 of the breath alert device 10 illustratesthe LED indicator 54 a having one wavelength yet at different lightintensities (i.e., displaying an enhanced intensity of blue light in onestate (in FIG. 1D) relative to another state as shown in FIG. 1C).

FIG. 1E illustrates a rear perspective view of the wearable analytebreath alert device 10 with one embodiment of the detector thresholdregion 22 in accordance with the preferred embodiment of the presentinvention. The rear face 24 of the breath alert device 10 comprises thesame elements as FIG. 1E except substituted with an enmeshed detectorthreshold region 84 more readily adapted to function as an audiblespeaker and/or to more readily filter aerosolized acetone molecules. Asshown in FIG. 1E, in some embodiments charging pins 26 are visible onthe rear exterior, facilitating docking into a desktop ornightstand-type charging port.

Notably, the breath alert device 10 is reversible in all of itsiterations, which means that the rear face 24 and the forward face 12can be fitted interchangeably into the outer casing 16. For example,FIG. 1C shows the front perspective view of the breath alert device 10with the rear face 24 facing away from the user's chest, but thereversible core 11 can in fact be removed from the outer casing 16 andreversed in orientation such that the insignia 13 points towards theuser's chest.

FIGS. 2A-2B illustrate the front perspective views of the reversiblecore 11 detached from and attached to the outer casing 16 of thewearable analyte breath alert device 10 respectively. The reversiblecore 11 fits into the outer casing 16 by snap fit, magnetic engagementmeans, screw fit or the like.

FIG. 3 illustrates a block diagram of the volatile organic compound(VOC) sensor 38 of the wearable analyte breath alert device 10 inaccordance with the preferred embodiment of the present invention andFIG. 9 illustrates a circuit diagram of the volatile organic compound(VOC) sensor 38 of the wearable analyte breath alert device 10. Asillustrated in FIG. 3 , the VOC sensor 38 comprises the central sensorcircuit 70, the alarm component 50 and a DC to DC element 42. Thecentral sensor circuit 70 is operably connected to the BLE element 56including microcontroller (MCU). In the preferred embodiment, the BLEelement 56 utilized is RL62M01A. FIGS. 7A-7C illustrate a circuitdiagram of the Bluetooth Low Energy (BLE) element 56 of the wearableanalyte breath alert device 10. The central sensor circuit 70 includesthe gas sensor unit 86 having the at least one nano gas sensor 64 andthe at least one heater 66, the sensor signal conditioning unit 88having the gain element 60 and the conversion element 62, and the A/Dinterface 90 having the analog to digital converter (ADC) 58 and thedigital to analog converter (DAC) 68. FIG. 5 illustrates a circuitdiagram of the central sensor circuit 70 of the wearable analyte breathalert device 10. The alarm component 50 includes the audio piezoactuator 52, the vibration element 48, and the tri-color light emittingdiode (LED) 54. FIG. 6 illustrates a circuit diagram of the alarmcomponent 50 of the wearable analyte breath alert device 10. The DC toDC element 42 includes the battery charger 40 and the battery 46 of atleast 800 mA/Hr. Preferably, the DC to DC element 42 is RT8025 and thebattery charger 40 is TP4054. Notably, the DAC 68 is operably connectinga heater voltage supply and a sensor voltage supply to the at least oneheater 66 and the at least one nano gas sensor 64, respectively.

In some embodiments, the battery 46 includes a capacity of three to fivedays. In other embodiments, the estimated battery capacity is 800 mAh.In the preferred embodiment, the battery 46 has a 3000 charge-dischargelife cycle. In some embodiments, the breath alert device 10 may have abattery indicator that will include a low battery feature to alert theuser to recharge. In some embodiments, in case of very low battery, thebreath alert device 10 may include a haptic actuator to warn ofimmediate impending shutdowns.

As described above, the user alerts include various alert capabilitiesincluding automated text messages, email messages, audio alerts, andhaptics. In operation, upon determination of blood glucose levels, thebreath alert device 10 will actuate the audio piezo actuator 52 untilstopped by the user. As illustrated in FIG. 3 , in one embodiment thetri-color LED 54 and the vibration element 48 permits coordinatedvibration alerts and colorized alerts. FIG. 3 further depicts thecentral sensor circuit 70 operably connected to the BLE element 56, theaudio piezo actuator 52, the DC to DC elements 42, and the batterycharger 30. Further, FIG. 3 shows that, internal to the central sensorcircuit 70, the DAC 68, the ADC 58, the gain element 60, the conversionelement 62, the at least one nano gas sensor 64 and the heater element66 are operably interconnected.

In the preferred embodiments, as shown in FIG. 3 , power is supplied tothe breath alert device 10 via a rechargeable 800 mAh Lithium Ionbattery 46. In some embodiments, battery condition is indicated by“low”, “ok”, “fully charged”, “time to charge”, and/or similarindicators known in the art. In other embodiments, the breath alertdevice 10 is able to continue detection while charging on a bedsidenightstand while the user sleeps. In some embodiments, the breath alertdevice 10 has a specified Bluetooth Low Energy connection indicator. Inthe preferred embodiment, the breath alert device 10 has a battery lifeof three to five days. In some embodiments, a charging cradle isprovided in combination with the provided sensor (see FIGS. 3-4 forsensor components). Notably, charging the battery does not interferewith the device's operation, such that glucose, acetone, and otherreadings may be processed, stored and retransmitted during chargingcycles. FIGS. 8A-8B illustrate a circuit diagram of the charger and thepower circuit of the wearable analyte breath alert device 10.

FIG. 4 illustrates a block diagram of the main processor module 72 ofthe wearable analyte breath alert device 10 in accordance with thepreferred embodiment of the present invention. The main processor module72 includes a pair of charging pins 26, the central sensor circuit 64, abuzzer 50, a tri-color LED 54, the vibration element 48 and the BLEelement 56. In some embodiments, an X axis measurement 82 of the mainprocessor module 72 comprises at least 60 mm, 50 mm, or 40 mm in length.In some embodiments, the Y axis measurement 80 of the main processormodule 72 comprises at least 40 mm, 30 mm, or 20 mm in length. In someembodiments, as depicted in FIG. 5 , a SPST sensor circuit 70 iscontemplated including a SPST microcontroller switches 74, an Analog toDigital Converter (ADC) 76 and a Digital to Analog Converter (DAC) 78.

As described above, FIG. 4 illustrates details of the main processormodule 72. In some embodiments, the main processor module 70 includesthe BLE element 56. The BLE element 56, preferably, includes RL62MO1Amodule with 2 MBbits flash memory including a microcontroller (MCU). Inother embodiments, the main processor module 72 includes auxiliarynonvolatile memory for OS backup and data recording. In someembodiments, the main processor module 72 is operably coupled to ahaptic device having at least a 3G vibration rating and an operablefrequency between 100 Hz and 400 Hz.

In some embodiments, the breath alert device 10 is used in a homesetting. In other embodiments, the breath alert device 10 is used in ahospital setting. In some embodiments, the breath alert device 10 alertsthe user via haptic, LED light array and/or voice alert and iswirelessly and operably connected to a smart device application. In thepreferred embodiment, the breath alert device 10 will optionally detecta single gas (i.e., acetone) or combination of gasses emitted from theuser's breath, and will indicate the presence of high or low blood sugarlevels. In some embodiments, when the breath alert device 10 is out ofrange or otherwise not able to connect to a smart device, then it willautomatically default to a “primary functions mode”. In this mode,gathered information may be stored or, alternatively, may be sent tonecessary third parties. In some embodiments, the user can set the highand low glucose alert levels in milligrams per deciliter (mg/dl) or inany alternative standard unit desired.

In the preferred embodiment, nano gas sensing is used for the gassensing feature. Nano gas sensing technology includes the utilization ofmetal oxide semiconductors wherein a signature Volatile Organic Compound(VOC) gas is detected. In some embodiments, the user is able to set thehigh and low glucose alert level in milligrams per deciliter (mg/dl) andstore the readings electronically in the breath alert device 10. Thestored glucose level will provide an informational gauge of the user'sglucose levels. Ultimately a physician is required to make clinicaldecisions for the user, and this technology facilitates a connectionwith the physician as glucose readings are readily transmissible tothird parties via Bluetooth and similar technologies. In someembodiments, the breath alert device 10 is customized for monitoringpatients with diabetes. Notably, the breath alert device 10 is alsowell-suited for (OTC) over the counter sale.

In the preferred embodiment, the nano gas sensor 64 (pre-event sensor)comprises a noninvasive ketosis analyzer. The nano gas sensor 64 isadapted to alert the user to pending changes in blood glucose levelsthrough the analysis of reliably emitted gases from the user's breath.As shown in FIG. 3 , the breath alert device 10 utilizes nano gassensing technology wherein a signature of VOC gases can be detected bynanoliter scale-sensitive sensors. This technology utilizes metal oxidesemiconductor nano sensors 64 that are extremely sensitive for detectingenvironmental gases. As shown in FIG. 3 , the breath alert device 10also includes an integral control board. This control board is optimizedto provide both visual and audible signals.

The nano sensor 64 of the breath alert device 10 is unique in that italerts the user in numerous ways including haptic, LED light array,programmable voice alert, and alert to a smart device via Bluetooth.These multi-modal alerts have a compounding effect; exponentiallyincreasing the likelihood that the user will recognize the alert.Further, the user can customize the alerts to, for example, only utilizehaptic alerts if an auditory signal is considered undesirable. In otherembodiments, the user can choose prerecorded voice clips coupled toalerts via the speaker of the breath alert device 10, a home smartdevice speaker, or phone speakers.

The plurality of holes 94 of the detector threshold region 22 of thebreath alert device 10 is capable of operating as both aerosol intakeholes and speaker holes. In some embodiments, the alarm component 50alerts the user when glucose levels are about to cross a preset high orlow threshold stating, for instance, “you are about to experience achange in your glucose level, please take appropriate action”. In someembodiments, the user can control the intensity and duration of thealarm component 50. For example, the user can choose to have a hapticsignal become more intense over a period of five seconds to indicatehigh glucose levels, and decrease in intensity over ten seconds toindicate low glucose levels.

FIG. 11 illustrates a front view of a wearable analyte breath alertdevice 28 in accordance with an alternate embodiment of the presentinvention. In the alternate embodiment, the wearable analyte breathalert device 28 is adaptable for use as a wristwatch. The wearableanalyte breath alert device 28 includes the same reversible core 11 asthat of the breath alert device 10. FIG. 11 illustrates the forward face12 having the in-line insignia 13, the front port 18, the LED indicator54, the side port 34 and the activation button 20 secured to a watchcasing 30 having a wrist clasp 36 and a plurality of clasping holes 32.

FIGS. 12A and 12B illustrate perspective views of the reversible core 11detached from and secured to the watch casing 30 of the wearable analytebreath alert device 28 in accordance with an alternate embodiment of thepresent invention. In FIG. 12B, the reversible core 11 is reversed,illustrating the rear face 24 having the detector threshold region 22secured to the watch casing 30. The watch casing 30 having the wristclasp 36 and the plurality of clasping holes 32 is made of materialcomposed of silicone rubber, nylon or other similar adjustable material.

FIGS. 13A-13B illustrate a wearable analyte breath alert device 92 inaccordance with another embodiment of the present invention. The breathalert device 92 of this embodiment can be clipped to the user's clothingor other personal items.

In one embodiment, the present application includes a ketone test systemin which the presence of ketones is quantitated by way of measuringvarious aerosolized compounds (i.e., direct aerosolized ketone analysisor acetone analysis). The acetone may be derived from decarboxylation ofacetoacetate, which is produced from apolysis or lipid peroxidation. Thesynthesis and degradation of such ketone bodies is therefore related toblood glucose levels. As is further known in the art, identification ofketones is used in the diagnosis and treatment of acidosis (a conditioncharacterized by abnormally high acidity of body fluids) or ketosis (acondition characterized by increased production of ketone bodies such asacetone) and for monitoring patients on ketogenic diets and patientswith diabetes.

In one embodiment, the outer casing 30 is in part or completely PC/ABSPlastic. As described above, in some embodiments these casing materialspermit the present application to be worn as a necklace. In someembodiments, the present application operably and wirelessly syncs witha phone application adapted to pair with the breath alert device 10. Inuse, the pairing permits the user to calibrate measured glucose alertlevels and to individually customize alert settings. In someembodiments, the alarm component 50 includes an alert timing means. Thealert timing means is programmable by the user at any desired timeinterval. For example, the user can program alerts and the recording ofglucose levels at least every 5 minutes, 15 minutes, every hour, and/orevery day. In the preferred embodiment, once the breath alert device 10is fully configured, the device 10 is operationally automated, whichmeans that the breath alert device 10 can run, collect data, and performall functions without the input of the user.

Further, in some embodiments the user can breathe directly into thebreath alert device 10 in order to take a glucose reading. In someembodiments, directly blowing into the breath alert device 10 sets offspecific mechanosensors and software systems that determine whether achange in glucose is temporally imminent. Notably, in the preferredembodiment, the nano sensor 64 of the breath alert device 10 issensitive enough to take glucose readings from a reasonable distancesuch that the user is not required to blow directly into the device forall measurements. In some embodiments, when the breath alert device 10is not able to connect via BLE element 56 (i.e., out of range, batteryon smart device dead, etc.) the breath alert device 10 will continue toperform its routine functions. In this disconnected state, for example,the breath alert device 10 simply cannot transmit the collected data tothe user's phone.

In some embodiments, the user identifying information is provided by thebreath alert device 10 in various forms. In some embodiments, the user'sname, allergy information, emergency contact information, and the likeare accessible through the smartphone or smart device applicationsoftware and may be automatically transmitted to emergency medicalpersonnel in the event that certain input information is coupled in thebreath alert device 10. For example, the breath alert device 10 on boardtrackers are adapted to measure both hypo or hyper glycemic state of theuser. When this information is coupled, the user has the ability toprogram the breath alert device 10 to automatically call and transmitidentifying information to 911, a doctor, or a loved one, and the like.

In some embodiments the device 10 will continue to take and recordreadings even when there is no suitable connection to any cloud serviceor external device. Once said connection is reestablished, the recordedreadings are transmitted at that time.

In some embodiments, the audio piezo actuator 52 of the breath alertdevice 10 is adaptable to use with the alarm element 50. In someembodiments, the audio piezo actuator 52 has a capacity of 80 db SPLbetween 1 KHz and 5 KHz. In other embodiments, the LED indicator 54comprise a high brightness LED with minimum 15 Lumen. In someembodiments, board to board connections may be made with a flat ribboncable.

In one embodiment, the functions described in the present applicationmay be performed under the control of a mobile application, such as aprogram contained on a smart phone 44 or smart watch. All of the methodsand tasks described herein may be performed and fully automated by acomputer system. The computer system may, in some cases, includemultiple distinct computers or computing devices (including, but notlimited to, physical servers, workstations, storage arrays, and cloudcomputing resources) that communicate and interoperate over a network toperform the described functions. Each such computing device typicallyincludes one or more processors for execution of program instructionsstored in a memory or other non-transitory computer-readable storagemedium (including, but not limited to, a solid-state storage device,disk drives, thumb drive and the like). The functions disclosed hereinmay be embodied in program instructions. The various functions disclosedherein may be implemented in application-specific circuitry of thesystem. Where the computer system includes multiple computing devices,these devices may, but need not, be co-located. In certain embodiments,a result of the disclosed methods and/or tasks may be persistentlystored by transforming physical storage devices, including thosedescribed herein, into a different state. In some embodiments, thecomputer system may be a cloud-based computing system.

In one embodiment, the functions described herein may be carried outusing an algorithm designed for accomplishing such functions. Thealgorithm may be a part of a processor of a device of the presentdisclosure (in particular, a wearable device) or a part of a processorof a computer system described herein. Depending on the embodiment, thefunctions of any method processes or algorithms described in the presentdisclosure can be performed in a different sequence from that disclosed.Moreover, in certain embodiments, the functions described herein can beperformed concurrently, for example, through multi-threaded processing,interrupt processing, or multiple processors or processor cores or onother parallel architectures. In certain embodiments, the functionsdescribed herein can be performed sequentially.

The illustrative logical blocks, modules, routines, and algorithm stepsdescribed in the present application can be implemented as electronichardware (e.g., ASICs or FPGA devices), computer software that runs ongeneral purpose computer hardware, or combinations of both. For example,various illustrative components, blocks, modules, and steps have beendescribed above generally in terms of their functionality. Whether suchfunctionality is implemented as specialized hardware versus softwarerunning on general-purpose hardware depends upon the particularapplication and design constraints imposed on the overall system. Thedescribed functionality can be implemented in varying ways for eachparticular application, but such implementation decisions should not beinterpreted as limiting the present disclosure to such implementation.

The illustrative logical blocks, modules, routines, and algorithm stepsdescribed in the present application can be implemented by a machine,such as a general purpose processor device, a digital signal processor(DSP), an application specific integrated circuit (ASIC), a fieldprogrammable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination of the foregoing. A general purpose processor device can bea microprocessor, but in the alternative, the processor device can be acontroller, microcontroller 56, or state machine, or combinations of theforegoing. A software module can reside in RAM memory, flash memory, ROMmemory, EPROM memory, EEPROM memory, registers, hard disk, a removabledisk, a CD-ROM, or any other form of a non-transitory computer-readablestorage medium. An exemplary storage medium can be coupled to theprocessor device such that the processor device can read informationfrom, and write information to, the storage medium. In the alternative,the storage medium can be integral to the processor device. Theprocessor device and the storage medium can reside in an ASIC. The ASICcan reside in a user terminal. In the alternative, the processor deviceand the storage medium can reside as discrete components in a userterminal.

In some embodiments, a variety of sensors may be used in the breathalert device 10 in addition to the nano sensor 64 described above. Inone embodiment, any sensor known in the art to detect an analyte ofinterest may be used. In one embodiment, any sensor known in the art todetect blood glucose or a VOC of interest may be used. In anotherembodiment, the sensor is a semiconductor metal oxide sensor, anelectrochemical sensor, a field effect transistor sensor, resistivesensors, a chemiresistive sensor, or capacitive sensors. In oneembodiment, a property of each of the foregoing sensors is altered uponinteraction with an analyte. In certain embodiments, the sensor may bemodified to show increased sensitivity and/or selectivity by modifyingthe sensor to increase or decrease adsorption and/or transductionefficiency for a specific analyte, including glucose, acetone, or a VOC.

The sensor comprises a sensor material capable of detecting the analyte(for example, a VOC). The analyte, on interacting with/binding to thesensor material, causes a change in a physical property, a chemicalproperty, and/or an electronic property of the material resulting in asignal. In one embodiment, the signal is directly correlated to thepresence, amount, or concentration of the analyte in the sample. In oneembodiment, the signal is a change in an electrical property, such as,but not limited to, a change in conductivity (resistance), a change incapacitance, or a change in current of the sensor material or the sensorcontaining the sensor material. The signal is analyzed by themicrocontroller to produce a result for a given analyte.

In certain embodiments, the VOC sensor 38 comprises a plurality ofsensors, with a subset of the plurality of sensors designed to detect aspecific analyte (for example, a specific VOC or acetone) such that anumber of distinct analytes may be detected by the sensor system.

In some embodiments, the nano sensor 64 comprises at least one sensor asdescribed herein and a data module in communication with the sensor forstoring the signal generated by the sensor. When more than one sensor ispresent, a data module is present for each sensor of the sensor system.The sensor and the data module may be a single element of multipleelements. The data module may transmit the signal to the controller or aseparate computing device (such as a smartphone, tablet, laptop orcomputer) and the signal is stored and/or processed by the controller ofthe device or a processor of the separate computing device.Alternatively, each sensor of the sensor system transmits the signaldirectly to the controller of the device or to a processor of theseparate computing device (such as a smartphone, tablet, laptop orcomputer) and the signal is stored and/or processed by the separatecomputing device.

In one embodiment, the nano sensor 64 described in the presentapplication is a metal oxide sensor. Resistance of the metal oxidesensing layer is altered when target analytes are present. In operation,oxidizing gases such as nitrogen dioxide and ozone cause resistance toincrease, while reducing gases like VOCs and carbon monoxide cause theresistance to go down. Regulating the heater power and/or doping themetal oxide layer can be used to adjust the selectivity of the sensors.For VOC detection, metal oxide sensors that show the highest sensitivityto reducing gasses are preferred. This typically means sensors with tinoxide, with and without dopants such as, but not limited to, tungsten,palladium, platinum, titanium, lanthanum, zinc and other dopants, heatedto temperatures between 300-700 degrees C. other oxides that may be usedinclude, but are not limited to TiC, Cr—C, MmCb, NiO, and CuO.Alternatively, metal oxide sensors that have different dopants can beused. For example, a tin oxide sensor and a tungsten-doped tin oxidesensor with or without different heater temperatures, can be used tovary selectivity to a subset of analytes.

In one embodiment, the wearable breath alert device 10, and/or method ofthe present application provides for the establishment of a baseline(also referred to herein as a “baseline value”) for a specific user. Thebaseline value reflects a result determined in the absence of ananalyte. The baseline value may be stored by the micro controller of thewearable breath alert device 10 and the baseline value may be subtractedfrom any value determined as described herein.

The wearable breath alert device 10 may also be trained to adjust aresult to a particular user. In one embodiment, a result is provided bythe wearable breath alert device 10. The result is stored by the breathalert device 10 and/or a separate computing device. The user then testsfor the physiological status by an independent means (for example, whenhypoglycemia is the physiological status, by measuring blood glucoselevels by a finger prick test or other prior art test). The bloodglucose level determined is provided (for example, through anapplication of the receiving device or an input on the wearable device).The independently determined result by the breath alert device 10 may benoted to be within an acceptable range for the physiological status oroutside an acceptable range for the physiological status. Theindependently determined result is then matched to the result obtainedwith the wearable device (for example, if the result obtained with thewearable device is a concentration of six VOCs and the independentlydetermined result is blood glucose concentration, the concentration ofthe six VOCs is matched to the corresponding glucose concentration).This training process may be repeated any number of times.

In certain embodiments, the training process is carried out when thebreath alert device 10 is initially worn by the user. In certainembodiments, the training process is carried out after the breath alertdevice 10 has been worn by the user for a period of time. Neuralnetworks, cluster analysis, and/or other artificial intelligence systemsmay also be used in the training process (for example, to extrapolateadditional training results from the received training process). Whenthe training process is carried out multiple times, a specific VOC or aspecific combination of VOCs may be identified that correlate with thegreatest accuracy and repeatability with the independently determinedresults. As such, through the training process, the nature of the VOCsdetected for each individual may be refined over time for each user.Neural networks, cluster analysis, and/or other artificial intelligencesystems may also be used in this analysis.

In addition, parameters of operation of the breath alert device 10 maybe determined for the user under specific conditions or based on certainparameters associated with the tests. As such, it may be determined thatcertain parameters adversely impact the accuracy of a result and whensuch a parameter is determined to be present, the presence of theparameter may be noted in a result or the value may be discarded. Incertain aspects of this embodiment, the controller determines andrecords a sampling parameter associated with a result. Such a samplingparameter includes, but is not limited to, i) the presence of anenvironmental factor; ii) a temporal factor (for example, the time atwhich the sampling process is initiated, terminated, and/or completed);iii) a dietary factor (for example, the time at which the user lastconsumed a food or beverage item or the consumption of a specific foodor beverage item); and iv) a physiologic factor (for example, the timeat which a specific activity undertaken by the user, the generalwell-being of the user); and v) a medication factor (for example, anyprescription medications or nonprescription items the user may betaking). The various sampling parameters may be input by the user, suchas through a receiving device, and then transmitted to the controller ofthe breath alert device 10 or may be obtained from a third party (forexample, for environmental conditions, or may be obtained by anadditional sensor on the wearable device).

The controller may tag a result with one or more of the samplingparameters. When a result obtained with the breath alert device 10 doesnot correlate with a result determined at the same general time byanother method, the sampling parameters can be evaluated to determine ifa particular sampling parameter is interfering with a result. Forexample, consider the following hypothetical scenario using the breathalert device 10. A result does not accurately provide for adetermination of the physiological status of the user (i.e., the user isnot suffering from or at risk for hypoglycemia). When the samplingparameters associated with the result are examined, it is determinedthat the relative humidity was over 30% and the time was 10:00 AM. Inadditional instances where a result did not accurately provide for adetermination of the physiological status of the user, it was determinedthat the relative humidity was over 30% and that the time was 1:00 PM.In this hypothetical scenario, relative humidity of 30% or greater maybe determined to be a sampling parameter that negatively impacts aresult, while the time at which the result was determined may bedetermined to be a sampling parameter that does not negatively impact aresult. The circuit diagram of a humidity and temperature sensor of thewearable analyte breath alert device 10 is illustrated in FIG. 10 .

FIG. 14 illustrates a flowchart of a method 100 for detecting acetone,ketones and other volatile organic compounds in the breath of the userutilizing the wearable analyte breath alert device. The present method100 alerts the user based on the concentration of acetone, ketones andother volatile organic compounds. The method 100 comprises the steps of:providing a wearable analyte breath alert device having a front port, adetector threshold region, a volatile organic compound (VOC) sensoroperably coupled to a Bluetooth Low Energy (BLE) element having amicrocontroller and an alarm component for non-invasive monitoring of ananalyte in a sample from a user, as indicated in block 102. Then,introducing the sample to the VOC sensor through the front port and thedetector threshold region of the wearable analyte breath alert device,as indicated in block 104. Introducing the sample to the VOC sensorincludes introducing the user's breath onto the front port and thedetector threshold region of the wearable analyte breath alert device.The method detects the presence of the analyte in the sample by an atleast one nano gas sensor in the VOC sensor, as indicated in block 106,and generates a signal by the at least one nano gas sensor based on thepresence, amount and concentration of the analyte in the sample, asindicated in block 108. Then, as indicated in block 110, transmittingthe signal to the microcontroller of the BLE element and analyzing thesignal by the microcontroller to produce a result, as indicated in block112. Finally, the alarm component alerts the user based on the resultfrom the microcontroller, as indicated in block 114.

The breath alert device 10 is used by the user to monitor one or moreanalytes. Such monitoring allows the user to monitor his/her healthstatus or glucose levels over time and avoid suffering from a givendisease or condition. As the breath alert device 10 of the presentdisclosure provides information regarding the analyte without requiringthe user to take steps to initiate or complete the monitoring process,the risk of non-compliance with analyte monitoring is decreased, with aresulting benefit to the health of the user.

In one embodiment, the present application provides a method forevaluating a physiological status of a user by non-invasive monitoringof the analyte in a sample from the user, the method comprising: a)providing a wearable device wherein the user wears the device; b)exposing a sensor system of the wearable device to the sample; c)detecting the analyte via the sensor system, wherein the sensor systemgenerates a signal in the presence of the analyte; d) analyzing thesignal to determine the presence, amount and/or concentration of theanalyte to produce a result; e) and optionally (i) providing the resultto the user; (ii) alerting the user of the result; and/or (iii)notifying the user if the result is within an acceptable range oroutside of an acceptable range for the physiological status.

Another embodiment provides a method for determining if the user issuffering from, likely to suffer from, or in danger of suffering from adisease or condition by non-invasive monitoring of the analyte in asample from the user, the method comprising: a) providing the breathalert device wherein the user wears the device; b) exposing the centralsensor circuit of the wearable device to the sample; c) detecting theanalyte via the sensor circuit, wherein the sensor circuit generates asignal in the presence of the analyte; d) analyzing the signal todetermine the presence, amount and/or concentration of the analyte toproduce a result; e) and optionally (i) providing the result to theuser; (ii) alerting the user of the result; and/or (iii) notifying theuser if the result is within an acceptable range or outside of anacceptable range for the disease of condition.

In one embodiment, when a physiological status is being evaluated, thephysiological status is hypoglycemia. In one embodiment, when aphysiological status is being evaluated, the physiological status is aninfection, a respiratory infection, a urinary infection, agastrointestinal infection, obesity, diabetes, type I diabetes, or typeII diabetes. In certain aspects of the methods described herein, thenon-invasive monitoring is accomplished without requiring the user toprovide a direct sample to the device (for example, exhaling directlyinto the front port 18 of the breath alert device 10.

In certain aspects of the methods described herein, the non-invasivemonitoring is accomplished without requiring the user to exhale into thefront port 18 of the breath alert device 10 to initiate the monitoringprocess, to complete the monitoring process, determine a result of themonitoring process, and/or view such results. In certain aspects of themethods described herein, the non-invasive monitoring is accomplishedwithout requiring an action of the user to initiate the monitoringprocess, to complete the monitoring process, determine a result of themonitoring process, and/or view such results.

Further, the present inventors contemplate a method to detect acetone,ketones and/or other volatile organic compounds in the breath of a user.Frist, a user is provided an apparatus including a forward face with anouter case, front port, and activation button, wherein the front portcomprises an intake for a gas sensor. The user then breathes into thefront port, where an electrical response is measured in the mainprocessor module. As described above, acetone, ketones, volatile organiccompounds, and other aerosolized compounds are present in the gas phaseof a user's breath, enabling measurement of glucose in a user'sbloodstream and noninvasive ketosis analysis. Next, an electricalresponse is registered due to a change in resistance of the gas sensor.A concentration measurement is then automatically recorded upon thedetection of the aerosolized gas concentration (i.e., acetone, ketoneand/or another volatile organic compound). This detection event isenabled by the detector threshold region, VOC sensor, SPST sensorcircuit, and other components described above. Next, an alarm componentalerts the user to the measurement of the detected compound at intervalscontrolled by the user or on demand. As noted above, the alarm componentmay include LED indicators, haptic alerts, vibration elements, and thelike.

The wearable breath alert device 10 may be any device described herein(i.e., not limited to necklace 10 and wristwatch 28, but includingclipped device 92 and other forms). The sample may be any sampledescribed herein. In one embodiment, the sample is an indirect sample.An indirect sample is a sample that is not introduced directly into theinto the front port 18 of the breath alert device 10. In one embodiment,the sample is co-mingled with the ambient environment of the user (forexample, ambient air) before being introduced into the device. In aparticular embodiment, the sample is ambient air that surrounds thewearable device and the user. When the sample is ambient air, theanalyte originates from or is derived from the user of the wearabledevice and becomes mixed with ambient air such that the target analyteis contained in the ambient air surrounding the user.

The analyte may be any analyte described herein and may be present inthe sample at any concentration described herein (for example, at aconcentration between 1 part per ppb and 10 ppm). In certainembodiments, the analyte is a VOC. In certain embodiments, the analyteis a VOC and the physiological status is hyperglycemia. In certainembodiments, the physiological status is hypoglycemia and the VOCdetected is: (1) acetone, methyl nitrate, pentyl nitrate (for example,2-pentyl nitrate), ethanol, methanol, propanol, methane, propane, ethylbenzene, isoprene, O-xylene, M/P-xylene, formaldehyde, acetaldehyde, orany combination of the foregoing; (2) acetone, methyl nitrate, pentylnitrate (for example, 2-pentyl nitrate), ethanol, methanol, propanol,methane, propane, ethyl benzene, isoprene or any combination of theforegoing; (3) acetone and methyl nitrate, pentyl nitrate (for example,2-pentyl nitrate), ethanol, methanol, propanol, methane, propane, ethylbenzene, isoprene, O-xylene, M/P-xylene, formaldehyde, acetaldehyde, orany combination of the foregoing; (4) acetone and methyl nitrate, pentylnitrate (for example, 2-pentyl nitrate), ethanol, methanol, propanol,methane, propane, ethyl benzene, isoprene, or any combination of theforegoing; (5) acetone and pentyl nitrate (for example, 2-pentylnitrate), methanol, propane, isoprene, or any combination of theforegoing; (6) ethanol and methyl nitrate, pentyl nitrate (for example,2-pentyl nitrate), acetone, methanol, propanol, methane, propane, ethylbenzene, isoprene, O-xylene, M/P-xylene, formaldehyde, acetaldehyde, orany combination of the foregoing; (7) ethanol and methyl nitrate, pentylnitrate (for example, 2-pentyl nitrate), ethanol, acetone, propanol,methane, propane, ethyl benzene, isoprene, or any combination of theforegoing; (8) ethanol and methyl nitrate, ethyl benzene, or anycombination of the foregoing; (9) isoprene and acetone, methyl nitrate,pentyl nitrate (for example, 2-pentyl nitrate), ethanol, methanol,propanol, methane, propane, ethyl benzene, MIP-xylene, formaldehyde,acetaldehyde, or any combination of the foregoing; 10) ethanol, methylnitrate, and ethyl benzene; or 11) acetone, pentyl nitrate (for example,2-pentyl nitrate), methanol, propane, and isoprene.

The foregoing description of the preferred embodiment of the presentinvention has been presented for the purpose of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise form disclosed. Many modifications andvariations are possible in light of the above teachings. It is intendedthat the scope of the present invention to not be limited by thisdetailed description, but by the claims and the equivalents to theclaims appended hereto.

What is claimed is:
 1. A method for detecting volatile organic compoundsin a wearable analyte breath alert device for non-invasive monitoring ofan analyte in a sample of aerosolized gas from a user, the methodcomprising: providing the breath alert device comprising an outercasing, a forward face secured to the outer casing, the forward facehaving an in-line insignia and at least one front port, the at least onefront port adapted to function as a gas sensing port or an evacuationport for evacuating a previous sample, wherein the breath alert devicefurther comprises a rear face opposite the forward face and secured tothe outer casing, the rear face having a detector threshold region, aside port and a tri-color light emitting diode (LED), the detectorthreshold region including a plurality of circular holes configured tofunction as gas sensor intake ports, speaker ports, and/or sampleevacuation ports, wherein the breath alert device further comprises areversible core positioned in between the outer casing, the forward faceand the rear face, the reversible core having a main processor module,and wherein the breath alert device further comprises a volatile organiccompound (VOC) sensor adapted to detect at least one volatile organiccompound of the user, the VOC sensor positioned on the main processormodule, the VOC sensor further comprising: a central sensor circuitoperably connected to a wireless communication element having amicrocontroller, the central sensor circuit including a gas sensor unithaving at least one nano gas sensor and at least one heater, aconditioning circuit for conversion and gain conditioning, and an A/Dinterface having an analog to digital converter and a digital to analogconverter; an alarm component having an audio piezo actuator and thetri-color light emitting diode (LED); and a DC to DC element having abattery charger and a battery; contacting the sample of aerosolized gaswith the VOC sensor through the at least one front port and the detectorthreshold region, the at least one nano gas sensor of the VOC sensordetecting the analyte in the sample and generating a signal which isdirectly correlated to the amount of the analyte in the sample;transmitting the signal to the microcontroller which analyzes the signalto produce a result for the analyte amount; and alerting via the alarmcomponent the user based on the result from the microcontroller.
 2. Themethod of claim 1 wherein the analyte is selected from the groupconsisting of: glucose, acetone, and ketones.
 3. The method of claim 1wherein the breath alert device further comprises an activation buttonthat provides an interface with the VOC sensor circuit, permitting theuser to set high glucose and low glucose alert levels and set alerttypes.
 4. The method of claim 1 wherein the tri color light emittingdiode (LED) includes colored lights configured to indicate low battery,high glucose level, low glucose level, battery charging, and pairing. 5.The method of claim 1 wherein the at least one nano gas sensor isconfigured to detect glucose, acetone, and ketones.
 6. The method ofclaim 1 wherein the alerting step alerts the user in at least one wayselected from the group consisting of: LED light, a programmable voicealert, and an alert to a smart device via the wireless communicationelement.
 7. The method of claim 1 wherein the wireless communicationelement activates the alarm component based on the signal generated bythe central sensor circuit, when the at least one nano gas sensordetects the analyte in the sample.